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Polysorbate 80

Test Specification...IP
Characters It occurs as an oily, colorless or brownish-yellow, clear or slightly opalescent liquid
Identification Test (A) Test (B) Test(C) Test(D) Test(E) (a)Infrared Absorption Spectrophotometry (b)Hydroxyl Value- Between 65 to 80 (c) Saponification Value- Between 45 to 55 (d) Composition of fatty acids (e) Specified Test. The solution becomes blue.
Solubility Dispersible in water, in anhydrous ethanol, in ethyl acetate and in methanol, practically insoluble in fatty oils and in liquid paraffin.
Relative density About 1.10
Viscosity About 400 mPa.s at 25OC
Acid Value Not more than 2.0
Hydroxyl Value Between 65 to 80
Peroxide Value Not more than 10.0
Saponification Value Between 45 to 55, determined on 4.0g
Composition of Fatty Acid a) Myristic Acid b) Palmitic Acid c) Palmitoleic Acid d) Stearic Acid e) Oleic Acid f) Linoleic Acid g) Linolenic Acid
  1. Not more than 5.0%
  2. Not more than 16.0%
  3. Not more than 8.0%
  4. Not more than 6.0%
  5. Not more than 58.0%
  6. Not more than 18.0%
  7. Not more than 4.0%
Ethylene Oxide Not more than 1 ppm
Dioxan Not more than 10 ppm
Water Not more than 3.0%
Total Ash Not more than 0.25%
Test Specification...FCC
Characters It occurs as a yellow to orange colored, oily liquid.
Identification Test(A) Test(B) Test(C) (a)Specified Test. The solution is strongly opalescent. (b) Specified Test. The bromine is decolorized (c) Specified test.
Solubility It is very soluble in water, producing a nearly colorless solution, and it is soluble in alcohol, in fixed oils, in ethyl acetate, and in toluene. It is insoluble in mineral oil.
Acid Value Not more than 2
1,4- Dioxane Not more than 10mg/kg
Hydroxyl Value Between 65 and 80
Lead Not more than 2mg/kg
Oleic acid Between 22 and 24 g per 100 g of sample
Residue on ignition Not more than 0.25%
Saponification value Between 45 and 55
Water Not more than 3.0%
Assay for Oxyethylene Content Not less than 65.0% and not more than 69.5% of oxyethylene groups, equivalent to between 96.5% and 103.5% of Polysorbate 80, calculated on the anhydrous basis.
Test Specification...USP
Characters It occurs as a lemon to amber colored, oily liquid having a faint characteristic odor.
Identification Test A Test B a) It gives test for Composition of Fatty Acid. b) Infrared Absorption
Solubility Very soluble in water, producing an odorless and practically colorless solution; soluble in alcohol and in ethyl acetate, insoluble in mineral oil.
Residue on ignition Not more than 0.25%
1. Ethylene dioxide 2. Dioxan
  1. Not more than 1 ppm
  2. Not more than 10 ppm
Specific gravity 1.06 to 1.09
Viscosity 300-500 centistokes at 25˚C
Acid value Not more than 2
Hydroxyl value 65-80
Peroxide value Not more than 10
Saponification value Between 45-55
Water determination Not more than 3.0%
Residual solvents Meets the requirement
Assay-Composition of Fatty Acids
  1. Myristic acid
  2. Palmitic acid
  3. Palmitoleic acid
  4. Stearic acid
  5. Oleic acid
  6. Linoleic acid
  7. Linolenic acid
  1. Not more than 5.0%
  2. Not more than 16.0%
  3. Not more than 8.0%
  4. Not more than 6.0%
  5. Not less than 58.0 %
  6. Not more than 18.0%
  7. Not more than 4.0%

Shelf life, Storage and Packing
It should be stored in a segregated area in a cool and ventilated place away from combustible materials. Keep in a tightly closed container, sealed until ready for use. It is packed in 25kg or 50kg HDPE bags or drums as required.

Other
GLP, cGMP (FDA) Approved, ISO 9001, ISO 14001, ISO 45001, ISO 17025, ISO 22000, FSSC 22000, FSSAI, Halal and Kosher certified.
We observe WHO Good manufacturing practice and Good laboratory practice.

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